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Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

NCT ID: NCT01397214

Last Updated: 2012-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS.

Phase I study divided into 3 parts written as belows.

Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers

Detailed Description

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Conditions

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Cachexia Anorexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Megace F

Megace F oral suspension

Group Type EXPERIMENTAL

Megace F

Intervention Type DRUG

Megace F oral suspension

Megace OS

Megace acetate oral suspension

Group Type ACTIVE_COMPARATOR

Megace OS

Intervention Type DRUG

Megace oral suspension

Interventions

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Megace F

Megace F oral suspension

Intervention Type DRUG

Megace OS

Megace oral suspension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

age: 20-55 years body weight: greater than 50kg written informed consent

Exclusion Criteria

known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-sang Yu, Dr.

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MGF-BR-CT-101

Identifier Type: -

Identifier Source: org_study_id